Posted by Michael Wonder on 12 Oct 2017
Janssen submits new drug application to U.S. FDA for apalutamide (ARN-509) to treat men with non-metastatic castration-resistant prostate cancer
11 October 2017 - First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk for Metastasis.
Janssen today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.
This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT). Men with non-metastatic CRPC with a rapidly rising PSA are at high-risk for developing metastatic disease. The primary endpoint of this study was metastasis free survival (MFS).1 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.4 The SPARTAN study results will be presented at a future medical meeting.
